Explainer · Brain & Mental Health
A tinnitus app beat a sham app by 20 points on a distress score in a 60-person randomized trial
Tinnitus has no cure and the therapy that helps most is hard to get. A Japanese trial put the useful parts of it into a phone app and tested it against an app that did nothing.
- A randomized trial in 60 adults with distressing chronic tinnitus, run for 16 weeks.
- Neither participants nor assessors knew who had the real app; the control app looked the same.
- Distress scores improved by about 20 points more in the app group than in the sham group.
- The gain held eight weeks after the therapeutic features were switched off.
- Sixty people is small, everyone was in Japan, and the app does not make the sound stop.
The standard advice for tinnitus is uncomfortable to give and to receive: there is no cure, and the thing that helps most is a course of therapy aimed not at the sound but at your relationship with it. Cognitive behavioral therapy has the best evidence in the field, and almost nobody can get it. Waiting lists are long, trained therapists are few, and the people most distressed are often the least able to travel to a weekly appointment.
That gap is the reason for the study. A Japanese team, reporting in JAMA Otolaryngology-Head and Neck Surgery, built the counseling and therapy elements into a phone app, then ran the test that most wellness apps never face: a randomized trial against a dummy version of itself.
What tinnitus distress actually measures
Tinnitus is a sound with no source outside the head, and its severity has surprisingly little to do with its loudness. MedlinePlus describes it plainly: tinnitus is often described as a ringing in the ears, though it also can sound like roaring, clicking, hissing, or buzzing.
What varies between people is how much room it takes up. The trial’s main measure, the Tinnitus Handicap Inventory, scores exactly that: concentration, sleep, mood, whether social situations become unbearable. At the start the average score was about 41, which is the moderate band, and it is where most people who seek help sit.
How the tinnitus app was tested against a sham
This is the part that separates the study from the app store. It was a double-blind, sham-controlled randomized clinical trial, conducted between September 2023 and February 2025 in individuals diagnosed with mild to severe chronic tinnitus.
Participants used either the therapeutic app or a sham control app that lacked the therapeutic functions. The sham looked and behaved like the real thing, so nobody could tell from the interface which version they had, which is the software equivalent of a placebo pill and unusual in digital health.
Sixty people took part, split evenly between the two apps, with a 16-week treatment phase followed by an 8-week follow-up phase. During the follow-up the therapeutic functions were switched off, leaving only a recording function, to see whether any benefit persisted once the treatment stopped.
What happened to the distress scores
The gap between the groups was large. At week 16, the therapeutic app group showed significantly greater improvement in scores compared with the sham-control app group, by about twenty points on the distress measure.
For context, twenty points on that scale is the difference between tinnitus dominating daily life and tinnitus being a nuisance you can work around. It is a clinically meaningful change rather than a statistical one.
The durability matters as much as the size. The therapeutic effect was maintained up to week 24, eight weeks after the app’s therapeutic content had been turned off. That is the signature you would want from a therapy that teaches something, as opposed to a device that masks a symptom while it is switched on.
Safety was unremarkable in the reassuring sense: tinnitus worsened in 1 patient in the sham-control app group, and no serious adverse events or device malfunctions with potential for health hazards were observed.
Why a sham-controlled app trial is rare and necessary
Most health apps are sold on before-and-after numbers, and tinnitus is a condition where those numbers mislead badly. People seek help when the symptom is at its worst, and it fluctuates, so scores improve afterwards regardless of what anyone does. Attention alone helps.
A sham app absorbs all of that. Both groups downloaded something, opened it daily, and believed they might be receiving treatment. What separates the groups at the end is the therapeutic content, and here that content accounted for a twenty-point gap.
What a 60-person tinnitus trial cannot show
The sample is small for a trial meant to change practice, and the participants were recruited in Japan and used an app in Japanese, so both the content and the cultural framing of illness may not transfer.
Sixteen weeks is also a short horizon for a condition people live with for decades, and the follow-up ran only eight weeks past the treatment. Whether the benefit survives a year is unknown.
And this was a prototype rather than a product. Nothing here tells you that a tinnitus app in your app store, built by someone else with different content, does anything at all.
What to take from the tinnitus app result
Two things, one hopeful and one practical. The hopeful one is that the treatment that works for tinnitus appears to survive being put in a phone, which matters enormously for access if it holds up in larger trials.
The practical one is what to ask for now. The active ingredient here is cognitive behavioral therapy, and that exists today, delivered by people. If tinnitus is wrecking your sleep or your concentration, that is the thing to ask about, rather than waiting for an app that has not yet been released, or buying one that has never been tested.
People also ask
What did the study find?
At week 16 the therapeutic app group showed significantly greater improvement in Tinnitus Handicap Inventory scores than the sham-control group, with a between-group difference in change of -20.4 (95% CI -28.2 to -12.6). The effect was maintained to week 24 (mean between-group difference -18.3; 95% CI -26.4 to -10.1). Tinnitus worsened in one patient in the sham group, and no serious adverse events were observed.
What is the Tinnitus Handicap Inventory?
A questionnaire that scores how much tinnitus interferes with life, from concentration and sleep to mood and social situations. The average score at the start here was about 41, which sits in the moderate range.
What was in the app?
Educational counseling and elements of cognitive behavioral therapy, the approach with the best evidence for tinnitus distress. It does not treat the sound itself; it targets the reaction to it.
What is a sham app?
A control app that looks and feels like the real one but lacks the therapeutic content, so participants cannot tell which they received. It is the software equivalent of a placebo pill, and it is what makes the comparison meaningful.
Does the app make tinnitus quieter?
That is not what it is for and not what was measured as the main outcome. The primary result is distress and functional impairment, which is what determines whether tinnitus ruins a life or becomes background.
Can I get this app?
It was a prototype tested in a trial, not a product on general release, and it was tested in Japanese. Anyone distressed by tinnitus should ask about cognitive behavioral therapy, which is the treatment this app was built from. This is general information rather than medical advice.